Announcement

February 1, 2017

SAFETY COMMUNICATION

On October 13, 2016, the FDA released an updated Safety Communication entitled, Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System.(http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm520191.htm.) This has understandably caused much concern among medical professionals as well as regulatory bodies, and has also brought about much misinformation.

As a valued CardioQuip customer, we want to assure you that no CardioQuip MCH-1000 series heater-cooler device has been reported with an NT-Mycobacterium-Chimaera contamination or infection. The only reported instance of microbial contamination in an MCH device occurred in late 2016, when an entire hospital water supply system was found to be contaminated with Legionella. Three of their twelve MCH devices were found to be contaminated with bacteria that originated from the water supply. Multiple investigations found that no patient infections originated from an MCH device. These findings were not surprising as the MCH does not provide a ready path for aerosolization of bacteria, and does not push air into the sterile field. In addition, the MCH's open access water path design allowed the hospital staff to fully disinfect the devices using the simple procedures detailed in the MCH Operator/Service Manual.

CardioQuip is communicating with the FDA to develop a more comprehensive understanding of these risk issues, and to determine the most appropriate and effective mitigation methods. We will keep you apprised of any relevant information as it becomes available. Please contact CardioQuip if you have any questions or concerns, or if you suspect that an MCH device has been involved in patient infections.